Instruction for use of Ceftonit

I. General information

1. Tradenamе of the veterinary medicinal product: Ceftonit

International nonproprietary name: ceftiofur hydrochloride

2. Ceftonit is a suspension of white to dark cream color.

Shelf-life of the medicinal product under specified conditions is 3 years from the date of manufacture, after opening – 28 days.

The use of the drug Ceftonit after the expiration date is prohibited.

3. Ceftonit is available in 50 ml and 100 ml glass vials sealed with rubber stoppers and aluminum caps with first opening control clips.

4. The veterinary medicinal product is stored in sealed original package, separately from food and feed, in a dry place, protected from direct sunlight, storage temperature range: 5°С to 25°С.

5. Ceftonit should be kept out of reach of children.

6. Unused product should be disposed of in accordance with the applicable legislation.

7. The veterinary drug Ceftonit is available without veterinary prescription

II. Сomposition

8. Pharmaceutical form: suspension for injections

1 ml of Ceftonit contains 50 mg of ceftiofur hydrochloride as an active substance, and excipients – up to 1 ml

III. Pharmacological properties

9. Ceftonit is an antibacterial medicinal product of the cephalosporins group.

10. Ceftiofur hydrochloride, an active substance of Ceftonit, is a third generation broad-spectrum cephalosporin antibiotic that has bactericidal effects on gram-negative and gram-positive bacteria, including ß-lactamase producing strains and some anaerobic bacteria: Escherichia coli, Pasteurella (Mannheimia) haemolytica, Pasteurella multocida, Haemophilus somnus, Actinobacillus pleuropneumoniae, Haemophilus parasuis, Salmonella cholerasuis, Streptococcus Suis, Streptococcus zooepidemicus, Streptococcus equi, Pasteurella spp., Staphilococcus spp., Actynomyces pyogenes, Salmonells typhimurium, Streptococcus agalactiae, S. dysgalactiae, S. bovis, Klebsiela, Citrobacter, Enterobacter, Bacillus spp., Proteus spp., Fusobacterium necrophorum and Porphiromonas assacharolytica (Bacteroides melaninogenicus).

Following parenteral administration, ceftiofur is rapidly metabolized to desfuroylceftiofur and reaches therapeutic concentration in the body within 1 hour; this concentration is maintained for 20 hours. Antibiotic is primarily excreted in the urine (more than 55%) and partly with faeces.

By the degree of its effect on the body, Ceftonit is classified as a low-risk substance (IV substance hazard category according to the GOST No. 12.1.007-76).

IV. Administration procedure

11. Ceftonit is used for the treatment of bacterial infections of the respiratory system caused by Pasteurella haemolytica, Pasteurella multocida, and Haemophilus somnus; to treat necrobacteriosis in cattle associated with Fusobacterium necrophorum and Porphiromonas assacharolytica (Bacteroides melaninogenicus); to treat acute endometritis in cows; and to treat respiratory infections in swine caused by Pasteurella haemolytica, Pasteurella multocida, Actinobacillus pleuropneumoniae and Streptococcus suis.

12. Contraindications include individual hypersensitivity of animals to ceftiofur or other β-lactam antibiotics. In case of an allergic reaction, the medication must be discontinued and antihistamines and/or epinephrine are to be prescribed.

13. In cattle, Ceftonit is injected subcutaneously once per day in a dose of 1 ml per 50 kg of animal body weight (1 mg of ceftiofur per 1 kg of animal body weight) as a treatment of the following diseases:

- Respiratory tract infections - for 3-5 days;

- Necrobacillosis - for 3 days;

- Endometritis - for 5 days.

In swine, the product is used to treat respiratory infections; it is administered intramuscularly, once a day, in a dose of 1 ml per 16 kg of animal weight (3 mg of ceftiofur per 1 kg of animal weight) for 3 days.

14. Overdose of the medicinal product results in decrease of animal appetite, an inflammatory reaction at the injection site.

15. No specific actions were reported at the first use and discontinuance of the drug.

16. Ceftonit is allowed for administration to animals during pregnancy and lactation.

17. Avoid missing prescribed dose administration as this may reduce treatment efficacy. When a dose is missed, continue to administer the product in the same dose and according to the same schedule.

18. No adverse reactions were observed at the administration of Ceftonit if administered subject to the instructions for use.

19. Mixing Ceftonit with other drugs in the same syringe is prohibited.

20. The slaughter of cattle and swine for meat is allowed no earlier than 8 and 5 days after the last dose of the product, respectively. If the animals must be slaughtered earlier than that, their meat can be used to feed fur-bearing animals.

The milk obtained from animals while they are being treated with Ceftonit may be used for human consumption without restrictions.

 

21. General rules of personal hygiene and safety measures required during work with medical agents should be followed when handling Ceftonit.

22. It is prohibited to drink, smoke or eat while handling the product. Wash your hands with soap and water after handling the product.

If product accidentally comes in contact with mucous membranes, flush them with copious amounts of water. In the case of allergic reactions or accidental ingestion of the product, you should contact your medical facility (you should take the instructions for use of the product or the product label with you).

23. Use of the empty vials of Ceftonit for domestic purposes is prohibited; they must be disposed of along with household waste.